Annals of Surgery – Magnetic augmentation of the lower esophageal sphincter.
Magnetic augmentation of the lower esophageal sphincter: results of a feasibility clinical trial.
Bonavina L, Saino GI, Bona D, Lipham J, Ganz RA, Dunn D, DeMeester T.
Source
IRCCS Policlinico San Donato, University of Milan, Via Morandi 30, 20097, San Donato Milanese, Milan, Italy. [email protected]
Abstract
BACKGROUND:
The high prevalence of gastroesophageal reflux disease continues to encourage the development of treatment modalities to fill the gap between acid-suppression therapy and the laparoscopic Nissen fundoplication. The Magnetic Sphincter Augmentation device has been designed to augment the lower esophageal sphincter barrier using magnetic force. A multi-center feasibility trial was done to evaluate safety andefficacy.
METHODS:
Patients with typical heartburn (at least partially responding to proton-pump inhibitors), abnormal esophageal acid exposure, and normal esophageal peristalsis were enrolled. Patients with hiatal hernia >3 cm were excluded from the study. The device was implanted laparoscopically around the distal esophagus.
RESULTS:
Over a 1-year period, 38 out of 41 enrolled patients underwent this procedure in 3 hospitals. No operative complications were recorded. A free diet was allowed since post-operative day one, and 97% of patients were discharged within 48 h. The mean follow-up was 209 days (range 12-434 days). The GERD-HRQL score decreased from 26.0 to 1.0 (p < 0.005). At 3 months post-operatively, 89% of patients were off anti-reflux medications, and 79% of patients had a normal 24-h pH test. All patients preserved the ability to belch. Mild dysphagia occurred in 45% of patients. No migrations or erosions of the device occurred.
CONCLUSIONS:
Laparoscopic implant of the MSA device is safe and well tolerated. It requires minimal surgical dissection and a short learning curve compared to the conventional Nissen fundoplication.
PMID: 18846406
